Small Bowel Motility in Patients With Systemic Sclerosis

Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05205239

Enrollment

Registered

2022-01-25

Start date

2021-07-01

Completion date

2022-08-31

Last updated

2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

System Sclerosis

Brief summary

Several studies using intestinal manometry have reported alterations in small bowel motility in patients with systemic sclerosis. Our aim is to apply endoluminal image analysis to stratify the intestinal motor dysfunction in these patients can be assessed by non-invasive techniques. Consecutive patients with systemic sclerosis referred to our institution will be prospectively investigated using automated non-invasive techniques developed in our laboratory. Intraluminal images of the gut were obtained by capsule endoscopy. Endoluminal image analysis will be performed with original, previously validated programs based on computer vision and machine learning techniques.

Interventions

DIAGNOSTIC_TESTEndoluminal image analysis by capsule endoscopy

Studies will be performed after discontinuation of medications that could affect gastrointestinal motility for at least 48 hours and overnight fast. Endoluminal images were obtained with the Pillcam capsule (Pillcam SB3 video capsule; Medtronic). Images will be obtained at a fixed 2 per second rate and recorded for a total of 8 hours with the subjects lying comfortably on a hospital bed and the trunk raised 30° above horizontal. Forty-five minutes after gastric exit, participants will be instructed to ingest a liquid meal (Ensure HN; Abbott; 300 mL,1 Kcal/mL). Endoluminal images of the small bowel will be analyzed with a computer program specifically developed in our laboratory for the evaluation of intestinal motility. This previously validated program is based on computer vision techniques, which allow the detection and quantification of contractile and non-contractile patterns characterizing small bowel motility.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Systemic sclerosis diagnosed by ACR criteria

Exclusion criteria

* Lung transplantation * End stage kidney disease

Design outcomes

Primary

Measure	Time frame
Motility index score	8 hours

Countries

Spain

Contacts

Primary ContactLuis Alcala, MD

lalcala@vhebron.net34 695101188

Backup ContactCarolina Malagelada, MD

cmalagelada@vhebron.net+34932746259

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026